Blood Pressure Monitor for High Blood Pressure
Palo Alto (17 mi)Age: 18 - 65
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: Aktiia SA
No Placebo Group
Approved in 2 jurisdictions
Trial Summary
What is the purpose of this trial?This study, with N = 85 participants minimum over 8 visits spread over 23 hours, has been designed to assess the accuracy and precision of the Blood Pressure and pulse rate values as generated by Aktiia.product-G0 for up to 23 hours after initialization in a cohort of subjects representative of the US population.
For the study, subjects will be asked to stay seated while measurements are taken at different timepoints.
Is the Aktiia Bracelet a promising treatment for high blood pressure?Yes, the Aktiia Bracelet is a promising treatment for high blood pressure. It is a wearable device that can accurately monitor blood pressure in different body positions over time. This makes it useful for tracking blood pressure in real-life situations, which can help in better understanding and managing high blood pressure.358911
What safety data is available for the Aktiia blood pressure monitor?The Aktiia blood pressure monitor, including its various versions like the Aktiia Bracelet and Aktiia Spot-check Optical Blood Pressure Monitoring Device, has undergone several validation studies. These studies have assessed its accuracy and precision in measuring blood pressure across different body positions and compared it to traditional methods. The device has been validated using protocols like the extended ISO 81060-2 and ANSI/AAMI/ISO 81060-2:2013 standards. Results indicate that the Aktiia monitor provides accurate blood pressure estimates comparable to traditional ambulatory blood pressure monitors, although precision can vary with body position. These studies suggest that the device is safe and effective for monitoring blood pressure in real-life conditions.6891112
What data supports the idea that Blood Pressure Monitor for High Blood Pressure is an effective treatment?The available research does not provide any data supporting the effectiveness of the Blood Pressure Monitor for High Blood Pressure as a treatment for high blood pressure. The studies mentioned focus on measuring eye pressure and do not relate to blood pressure monitoring or its effectiveness in treating high blood pressure.124710
Do I have to stop taking my current medications for the trial?The trial protocol does not specify if you need to stop taking your current medications. However, if you are taking a prescription blood thinner, you cannot participate in the study.
Eligibility Criteria
This trial is for at least 85 adults with high blood pressure, representative of the US population. Participants will need to be available for 8 visits over a day and stay seated during measurements.Inclusion Criteria
I am between 22 and 59 years old.
Exclusion Criteria
I have a clotting disorder or am on prescription blood thinners.
I am not pregnant nor trying to become pregnant, or I cannot become pregnant.
I have a heart condition with irregular beats that can cause weak or unstable blood pressure.
Treatment Details
The study tests the Aktiia Spot-check Optical Blood Pressure Monitoring Device's accuracy in measuring blood pressure and pulse rate against standard methods, over a period of up to 23 hours.
1Treatment groups
Experimental Treatment
Group I: Aktiia.product-G0 device under testExperimental Treatment1 Intervention
Subjects will be asked to stay seated while blood pressure and pulse rate measurements are taken at different timepoints with the device under test and references.
Find a clinic near you
Research locations nearbySelect from list below to view details:
Parameters Research LaboratoryBroomfield, CO
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Who is running the clinical trial?
Aktiia SALead Sponsor
References
[Measurement of arterial tension at the eye with the Stepanik arteriotonograph (author's transl)]. [2009]Comparative measurements of the ophthalmic artery pressure (using the Stepanik-ArteriotonographTM) and the brachial arterial pressure (sphygmomanometry according to Riva-Rocci) in 110 eyes are presented. There was a significant correlation (p less than 0,01) between both parameters. The mean systolic ophthalmic artery pressure was 114,5 mmHg, the diastolic pressure was 81,2 mmHg. The ipsilateral mean systolic brachial arterial pressure was 134,5 mmHg, the mean diastolic pressure 88,2 mmHg. In 7 eyes the ophthalmic pressure was exceeding the systolic brachial pressure, in 26 eyes the diastolic brachial pressure. 78% of the differences of paired measurements were within 0 and 10 mmHg (on the average 4,97 mmHg in the systolic readings and 4,30 mmHg in the diastolic readings). After repeated measurements with the arteriotonograph a significant increase of the ophthalmic arterial pressure was noted. The explanation of this phenomenon might be a ocular-vascular reflex produced by the compression of the globe into the orbit. The methodological limits of the arteriotonograph and the clinical significances of the present results are discussed.
Portable tonometers: a clinical comparison of applanation and indentation devices. [2006]Optometric services to outpatient clinics, nursing homes and hospitals require portable equipment for ocular assessment. Of the various tonometric methods available, Goldmann applanation tonometry remains the standard. We present a clinical comparison of the hand-held version of Goldmann's instrument (Perkins tonometer) and the less expensive Schiotz tonometer. In a clinical comparison, we measured the intraocular pressure (IOP) of 51 inpatient and outpatient veterans (100 eyes) during routine examination. In each case the Perkins applanation tonometer was used first. This measurement was followed by IOP measurements using the Schiotz indentation tonometer with the 7.5 g and 5.5 g plunger loads. Plunger loads were alternated so that each was used, initially, 50% of the time. Good correlations, ranging from +.85 to +.68, were achieved between the applanation and indentation modes. Compact portability, lower cost and comparable reliability make the Schiotz tonometer a viable option for IOP screening.
Validation of the Oregon Scientific BPU 330 for self-monitoring of blood pressure according to the International Protocol. [2021]Extensive marketing of devices for self-measurement of blood pressure has created a need for purchasers to be able to satisfy themselves that such devices have been evaluated according to agreed criteria. The Oregon Scientific BPU 330 blood pressure monitor is an electronic device for upper arm measurement. This study assessed the accuracy of the Oregon Scientific BPU 330 blood pressure monitor according to the International Protocol by the Working Group on Blood Pressure Monitoring of the European Society of Hypertension for validation of blood pressure measuring devices.
Schiotz tonometry accurately measures intraocular pressure in Boston type 1 keratoprosthesis eyes. [2022]To evaluate the location of the eye and tonometry device that provides the most accurate intraocular pressure (IOP) measurements in eyes with Boston type 1 keratoprosthesis.
Validation of the Pangao PG-800A36 automatic wrist blood pressure monitor according to the European Society of Hypertension and the British Hypertension Society protocols. [2019]The aim of this study was to validate the PG-800A36 automatic wrist blood pressure monitor according to the European Society of Hypertension International Protocol (ESH-IP) revision 2010 and the British Hypertension Society (BHS) protocols.
Are cuffless devices challenged enough? Design of a validation protocol for ambulatory blood pressure monitors at the wrist: the case of the Aktiia Bracelet. [2020]The US and European guidelines for the diagnosis and management of hypertension recommend the introduction of systematic home and night Blood Pressure (BP) monitoring. Fully-automated wearable devices can address the needs of patients and clinicians by improving comfort while achieving measurement accuracy. Often located at the wrist and based on indirect BP measurements, these devices must address the challenges of ambulatory scenarios. New validation strategies are needed, but little guidance has been published so far.In this work, we propose an experimental protocol for the validation of cuffless wrist BP monitors that addresses ambulatory environment challenges in a controlled experimental setting. The protocol assesses the robustness of the measurement for different body postures, the ability of the device to track BP changes, and its ability to deal with hydrostatic pressure changes induced by different arm heights.Performance testing using Aktiia Bracelet is provided as an illustration. The results of this pilot study indicate that the Aktiia Bracelet can generate accurate BP estimates for sitting and lying positions and is not affected by hydrostatic pressure perturbations.Clinical Relevance- Automated cuffless BP monitoring is opening a new chapter in the way patients are being diagnosed and managed. This paper provides a guidance on how to assess the clinical utility of such devices when used in different body positions.
Comparative Evaluation of Rebound and Perkins Tonometers in Pediatric Glaucoma With Varied Corneal Characteristics. [2023]Icare tonometer overestimated intraocular pressure (IOP) as compared with Perkins and this variation was higher in IOP>19 mm Hg and corneal opacity in patients with pediatric glaucoma.
Blood pressure from the optical Aktiia Bracelet: a 1-month validation study using an extended ISO81060-2 protocol adapted for a cuffless wrist device. [2023]The objective of this study (NCT04027777) was to assess the accuracy and precision of the Aktiia Bracelet, a CE-marked noninvasive optical blood pressure (BP) monitor worn at the wrist, over a period of 1 month.
Validation of the optical Aktiia bracelet in different body positions for the persistent monitoring of blood pressure. [2022]The diagnosis of hypertension and the adjustment of antihypertensive drugs are evolving from isolated measurements performed at the physician offices to the full phenotyping of patients in real-life conditions. Indeed, the strongest predictor of cardiovascular risk comes from night measurements. The aim of this study was to demonstrate that a wearable device (the Aktiia Bracelet) can accurately estimate BP in the most common body positions of daily life and thus become a candidate solution for the BP phenotyping of patients. We recruited 91 patients with BP ranging from low to hypertensive levels and compared BP values from the Aktiia Bracelet against auscultatory reference values for 4 weeks according to an extended ISO 81060-2 protocol. After initializing on day one, the observed means and standard deviations of differences for systolic BP were of 0.46 ± 7.75 mmHg in the sitting position, - 2.44 ± 10.15 mmHg in the lying, - 3.02 ± 6.10 mmHg in the sitting with the device on the lap, and - 0.62 ± 12.51 mmHg in the standing position. Differences for diastolic BP readings were respectively of 0.39 ± 6.86 mmHg, - 1.93 ± 7.65 mmHg, - 4.22 ± 6.56 mmHg and - 4.85 ± 9.11 mmHg. This study demonstrates that a wearable device can accurately estimate BP in the most common body positions compared to auscultation, although precision varies across positions. While wearable persistent BP monitors have the potential to facilitate the identification of individual BP phenotypes at scale, their prognostic value for cardiovascular events and its association with target organ damage will need cross-sectional and longitudinal studies. Deploying this technology at a community level may be also useful to drive public health interventions against the epidemy of hypertension.
Comparison of Two Tonometers in the Evaluation of 24-Hour Intraocular Pressure and Mean Ocular Perfusion Pressure in Patients with Thyroid-Associated Ophthalmopathy. [2022]The aim of the study is to compare a non-contact tonometer (NCT) and goldmann applannation tonometer (GAT) in the evaluation of intraocular pressure (IOP) and mean ocular perfusion pressure (MOPP) in patients with thyroid-associated ophthalmopathy (TAO).
Validation of the Aktiia blood pressure cuff for clinical use according to the ANSI/AAMI/ISO 81060-2:2013 protocol. [2023]Assess the accuracy and precision of the Aktiia initialization oscillometric upper-arm cuff device (Aktiia SA, Neuchâtel, Switzerland) for home blood pressure (BP) monitoring in the general population according to the American National Standards Institute / Association for the Advancement of Medical Instrumentation/International Organization for Standardization (ANSI/AAMI/ISO) 81060-2:2013 standard.
Aktiia cuffless blood pressure monitor yields equivalent daytime blood pressure measurements compared to a 24-h ambulatory blood pressure monitor: Preliminary results from a prospective single-center study. [2023]In this preliminary study, we compared daytime blood pressure (BP) measurements performed by a commercially available cuffless-and continual-BP monitor (Aktiia monitor, Neuchâtel, Switzerland) and a traditional ambulatory BP monitor (ABPM; Dyasis 3, Novacor, Paris, France) from 52 patients enrolled in a 12-week cardiac rehabilitation (CR) program (Neuchâtel, Switzerland). Daytime (9am-9pm) systolic (SBP) and diastolic (DBP) BP from 7-day averaged data from Aktiia monitor were compared to 1-day averaged BP data from ABPM. No significant differences were found between the Aktiia monitor and the ABPM for SBP (μ ± σ [95% confidence interval]: 1.6 ± 10.5 [-1.5, 4.6] mmHg, P = 0.306; correlation [R2]: 0.70; ± 10/ ± 15 mmHg agreements: 60%, 84%). Marginally non-significant bias was found for DBP (-2.2 ± 8.0 [-4.5, 0.1] mmHg, P = 0.058; R2: 0.66; ±10/±15 mmHg agreements: 78%, 96%). These intermediate results show that daytime BP measurements using the Aktiia monitor generate data comparable to that of an ABPM monitor.